EUCTR2015-000222-11-GB进行中（未招募）1 期
A phase II, randomised, double-blind, placebo- controlled, multi-site, parallel group clinical trial to examine ketamine as a pharmacological treatment for alcohol dependence in an alcohol dependent population. - KARE: Ketamine for reduction of Alcoholic Relapse Version 1
niversity College London0 个研究点目标入组 96 人开始时间: 2020年7月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •18 - 60 years old
- •Meet either a) DSM-5 criteria for severe alcohol use disorder and b) DSM-IV criteria for alcohol dependence
- •Currently abstinent (breathlyser BAC level 0.02 and negative urine drug and alcohol screen)
- •Minimum of mild depression(>14 on Beck Depression Inventory-II)
- •Capacity to give informed consent as defined by GCP guidelines
- •Willing and able to wear a SCRAM-X bracelet for 6 months
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation and inform the trial if pregnancy occurs
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment and on day of first treatment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Currently taking any other relapse prevention medication or anti-depressants
- •Uncontrolled hypertension, systolic 140mm Hg or greater and diastolic 90mm Hg or greater
- •< 16 or > 35 BMI
- •History of psychosis, or in a first-degree relative; co-morbid current psychiatric diagnosis excluding depression as identified by DSM-5 or DSM-IV SCID
- •Previous or current diagnosis of substance dependence / severe substance misuse disorder
- •History of neuropsychological difficulties
- •One or more previous confirmed seizures
- •Currently taking daily prescribed medication contraindicated in the Summary of Product Characteristics with ketamine:
- •Barbiturates and/or narcotics
- •Halogenated anaesthetics
- •Atracurium and tubocurarine
- •Central nervous system (CNS) depressants (e.g. phenothiazines, sedating H1 – blockers or skeletal muscle relaxants)
- •Anxiolytics, sedatives and hypnotics
- •Thiopental, thyroid hormones
- •Antihypertensive agents
- •Theophylline and methylxanthine
- •OR psychotropic drug use at screening assessment or during treatment weeks
- •Liver function tests > 3 times normal levels
- •Where there are Special warnings or precautions for use according to the Summary of Product Characteristics where risk vs benefit ratio is not in favour of giving ketamine, with assessment made by physical examination by medically qualified trial personnel, self-report or inspection of the medical notes:
- •Acute intermittent porphyria
- •Dehydration or hypovolemia
- •Hyperthyroidism, or patients receiving thyroid replacement
- •Pulmonary or upper respiratory tract infection
- •Severe Coronary artery disease, Cerebrovascular accident or cerebral trauma
- •Known glaucoma or globe injuries
- •Neurological condition/brain damage
- •Intracranial mass lesions, presence of head injury or hydrocephalus
- •Suicidal ideation
- •Not willing to use effective contraception or (females) take pregnancy test
- •Allergic reaction to ketamine
- •> 10 previous detoxifications from alcohol
- •Pregnant or Breastfeeding
- •Allergies to excipients of Investigational Medicinal Product and placebo
- •Use of another investigational medicinal product that is likely to interfere with the study medication within 3 months of study enrolment
研究者
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